Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/6/2016
Class lI:
PRODUCT
Cios Alpha, mobile X-ray system.
Recall Number Z-1278-2016
REASON
Software issues on Cios Alpha mobile C-Arm system
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 2/19/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
89 systems
DISTRIBUTION
Nationwide Distribution
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software
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Next public offerings:
Medical Device Cybersecurity (Public or Private)
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2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
Next public offering: TBD
